Ep. 351 - Gilead's Arcellx Buy. Plus: ctDNA as Surrogate Endpoint

Gilead is acquiring Arcellx for $7.8 billion up front three years after forging a partnership with the biotech around a cell therapy for multiple myeloma. On the latest BioCentury This Week podcast, BioCentury’s analysts assess what the deal does for the Foster City, Calif.-based biotech’s pipeline.
The analysts also discuss the case for using ctDNA as a surrogate endpoint for early cancer trials.
Turning to Washington, Steve Usdin offers his takeaways from last week’s PhRMA Forum, which focused on China and the Trump administration’s most favored nation (MFN) drug pricing policy, and on the lessons that can be drawn from FDA’s about-face on the recent vaccine application from Moderna.

View full story: https://www.biocentury.com/article/658516

#BiotechMA #MultipleMyeloma #ctDNA #DrugPricingPolicy #FDA

00:00 - Introduction
02:34 - Gilead's Arcellx Buy
11:14 - ctDNA Surrogate Endpoints
21:59 - PhRMA Forum Takeaways
29:19 - FDA Moderna U-turn

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

Transcript

0:00

[AI-generated transcript.]

Jeff Cranmer: 0:01

Gilead is acquiring Arcellx for nearly $8 billion upfront a little more than three years after forging a partnership with the biotech around a cell therapy for multiple myeloma, we take a look at the deal on this week's BioCentury This Week podcast. Plus optimization and validation are needed to achieve ctDNA highest priority application surrogate endpoints for early cancer trials. And we'll have Steve Usdin's takeaways from last week's PhRMA forum. Steve also gives his point of view on FDA's Moderna U-Turn. I'm Jeff Cranmer, host of the BioCentury's This Week podcast, and joining me today are my colleagues.

Paul Bonanos: 0:59

Paul Bonanos, Director of Biopharma Intelligence.

Lauren Martz: 1:02

Lauren Marts, Executive Director of Biopharma Intelligence.

Simone Fishburn: 1:05

Simone Fishburn, Editor in Chief.

Steve Usdin: 1:08

And Steve Usdin, Washington Editor.

Jeff Cranmer: 1:11

Okay. we have the BioCentury BayHelix East-West Summit coming up in a matter of weeks in Seoul. We're hoping to see you there. We're going to introduce a new exclusive opportunity for our subscribers, the BioCentury Lounge. It will be a cool, dedicated space designed to connect, recharge, and inspire conversation among industry leaders. Also at the conference, uh, if you're going well, it's not too late, you know, I realize it's a little bit of a ways, uh, from France or Washington and folks in the Northeast are probably gonna be snowed under for quite some time and unable to get to the airport. But if you're in Japan, elsewhere in Korea, China, hop on a plane and head over to Seoul to join us. We will have a special excursion on the heels of the conference to Daejeon, it's been called Korea's Silicon Valley. it's included in the price of admission for the conference, and you'll get to visit local biotechs and network with industry leaders in Daejeon. You can RSVP right now to our colleague Brian Denker at conferences at BioCentury.com. It's gonna be a great trip and we hope to see you at the East-West Summit. Alright, Gilead, acquiring Arcellx, 7.8 billion. Paul, you've been looking into this. What have you found?

Paul Bonanos: 2:44

Sure. Um, well, um, as you said, arcellx is already partnered with Gilead, so, in a way Gilead is sort of buying out the rest of the economics in its own deal. And most of that deal from 2022 has centered on a CAR T therapy called anito-cel. I'll spare you the longer name. There is a longer name, but we'll use that one today, anito-cel. And like a couple of other CAR Ts for multiple myeloma that are already approved, it has a familiar target BCMA. The same as the ones from Johnson & Johnson and Bristol. Arcellx uses a different binding technology of its own, and the company believes that that confers advantages, uh, in safety. there's a lack of, uh, certain neuro toxicities, for example, Parkinson's seen in relatively low rates for, uh, Carvykti, that's the J&J one. And also manufacturing. They say that they can um produce shorter turnaround times. J&J has had some difficulty scaling up over the years to meet demand. And Arcellx believes they can do better. They already do have a manufacturing partner, which is Gilead, the company buying it. So, uh, anito-cel is already under FDA review in a fourth line setting for multiple myeloma. Arcellx says they will have an abundance supply at launch and we'll be able to scale to meet full demand by 2027. There's also a Phase III trial underway in earlier lines as early as second line. Like I said, the deal gives Gilead full control, full economics, it would've owed milestones and royalties to Arcellx and all that goes away now. Approval seems likely, the PDUFA date is just before Christmas. The data looked good, 96% objective response rate, overall survival is 83% at two years. And high rates of, uh, MRD negativity too. And for Gilead, you know, it's, it's a fit, remember, Gilead owns Kite Pharma, that's the organization that's been working with Arcellx all along. And Kite sells two CAR Ts already for other lymphomas and leukemias, not multiple myeloma. we had a story even in, at the time of the partnership, 2022, about how Arcellx would benefit from Kites commercial and operational and manufacturing strength. And now Arcellx is just going right into that unit. So the, uh, price is $115 a share for the takeout that's, above Arcellx's all time high before today. And, um, at 7.8 billion, the price would be, so it's the biggest among biotech M&A deals this year, but it's still early in the year. And for context, there were about six or seven larger deals last year. There is a CVR associated with it, we've been seeing more of those lately. That could add, a sum somewhere in the 300 million range to the total price, it's $5 a share. and that's contingent on anito-cel meeting a cumulative sales threshold of 6 billion by the end of the decade.

Jeff Cranmer: 5:32

And a CVR, of course, contingent value right. We've been seeing more and more of, uh, Lauren, do you have any take on the, on the deal? I know you've been following the cell therapy space, uh, quite closely.

Lauren Martz: 5:46

I think that. Paul summarized it really well. This is a competitor for Carvykti, which has been incredibly successful. I, I think it remains to be seen though whether there is that manufacturing advantage because what we've seen J&J report with Carvykti is that the actual vein to vein time for patients is much longer than the manufacturing time that they've reported for this product. It's taken a very many years to ramp up to address the percentage of eligible patients that they are addressing now, which I think is, you know, is a fraction of those that they could address. This is a second line approved therapy and here we're talking about, Arcellx potentially getting maybe a fourth line approval. So I think there's a lot that needs to play out. It'll be interesting to see how this drug is used in the fourth line setting given the fact that we have a second line BCMA CAR T approved. And yeah, whether they're able to ramp up at, at a similar speed to J&J or, or potentially better. I think it's early to tell, but efficacy wise looks very similar on the response rates. We don't have a ton of durability data yet, which will be important going forward because people are looking to CAR Ts as a long term, potentially curative, almost therapy, um, especially in multiple myeloma.

Simone Fishburn: 7:02

So Lauren at a higher level, um, it's been kind of a rough year for cell therapies. and you know, within CAR Ts, you know, most of the excitement of course has been around in vivo CAR Ts. Obviously this is a validated targeted technology in this indication. Sort of wondering if you think that this is indicative of anything broader in terms of enthusiasm or do you think this is still just really a multiple myeloma play here?

Lauren Martz: 7:30

I think when we're talking about in vivo CAR Ts as competition, especially in multiple myeloma, it's just very early, you know, in that space we're seeing individual patient results from IITs in China. We, we just don't have the data yet, and I think going up against. A cell therapy that almost every patient you're giving it to responds to, and most patients as Paul mentioned, above 80% at two years still surviving. I, I think again, we need to see more durability data. But efficacy, the bar is so high with these BCMA CAR Ts, the autologous CAR Ts in multiple myeloma. I think where we might see similar efficacy but maybe a commercial advantage would be a rapid manufacturing CAR T. But I think when you're thinking about how this compares with, with the in vivo approaches, it's just, there's still a lot of time for these autologous CAR Ts, and I think this is a reflection of that. You know, there's plenty of markets still out there.

Simone Fishburn: 8:32

So is this deal really about that single asset or is there an ongoing pipeline and future of CAR T that Gilead could be tapping into here?

Paul Bonanos: 8:43

I'm glad you asked, I mentioned that the partnership was originally struck in 2022. They actually modified and expanded the partnership in 2023, and Gilead has exercised an option on another BCMA targeting therapy cell therapy from Arcellx. that uses an adaptable dosing technology and is kind of a next generation one, ACLX-001. That also comes into Kite's purview at this point. And there is at least one other program Arcellx has described in its pipeline that goes to Gilead as well. It's also true that anito-cel has undergone some Phase I testing outside of oncology in, uh, myasthenia gravis. I don't think Gilead had its rights outside of oncology under the original deal, so I think this gives an expanded, uh, set of indications to Gilead as well.

Jeff Cranmer: 9:32

and Paul, it certainly looks like one of the biggest deals that Gilead has done in the past few years they've had a, few deals with upfront, around 200 million 250 million with total deal values approaching 2 billion. But, uh, certainly nothing this big since I believe the, Cymabay acquisition in 2024, and that was 4.3 billion upfront. So, good play by Gilead and uh, I know they're actively building new buildings over there in Foster City. So, uh, we will see what's next and how this deal plays out for them. All right, we're gonna take a quick break and then we're gonna come back and talk ctDNA.

Alanna Farro: 10:27

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Jeff Cranmer: 11:14

Alright, we're back on the BioCentury's This Week podcast. We're gonna turn to circulating tumor DNA, and its use as a surrogate endpoint in solid tumor studies. Lauren, there was a Friends of Cancer Research meeting on Modernizing Oncology endpoints, earlier this month. You tuned in, what did you learn?

Lauren Martz: 11:42

So, as you mentioned, we're talking about the need for standards and the need for prospective trials for circulating tumor DNA, to become a measurement in surrogate endpoints. That's not new. We've been writing about this for several years. What's new, what, what I think is new from the discussion that I heard at that meeting and from, uh, speaking with people outside of the meeting, is the fact that it's now more refined. We now have a better sense of what actually needs to happen for ctDNA to become, you know, the, the measurement for surrogate endpoints in solid tumor trials. We also have a bit of a roadmap for how to make that happen through this measurable residual disease negativity endpoint in multiple myeloma. we just saw, um, FDA release draft guidance for that, which is sort of a similar early intermediate endpoint concept, a ctDNA clearance or, reduction in solid tumors. So ctDNA, is the DNA, that's shed by tumors, by cancer cells when they die either naturally or when you treat them. Generally it seems to correlate with the tumor burden that a patient has. So the reason that, um, there's a lot of excitement around this technology, uh, measuring this as a surrogate endpoint is because. It would be, you know, a very minimally invasive, blood-based biomarker that could be more sensitive and could provide an earlier indication of whether a tumor is progressing or whether a tumor is responding to treatment than the traditional radiographic imaging that we have. So where it stands now based on what we've heard at this meeting and, and elsewhere, is that there is evidence, retrospective clinical trial evidence, specifically from the CT Monitor program that is being sponsored by Friends of Cancer Research that shows that there is a correlation between reducing ctDNA and improving survival or, and improved survival in clinical trials. But this is retrospective studies and it's advanced cancers. What needs to happen for this to be a really useful clinical surrogate endpoint is to do prospective studies where you don't have missing data and to do this in earlier stage cancer settings where you actually need that earlier intermediate endpoint because the trials are long, patients are living longer. There are lots of confounding variables, like a lot happens between when a patient stops taking this drug and when, when they would ultimately die. If it's an early stage cancer setting. The challenge now is trying to make this validation in that early setting.

Steve Usdin: 14:29

And what's the roadmap to, to doing that?'cause it's not, in the obvious economic interest of any single company to invest in that, right?.

Simone Fishburn: 14:38

Okay. Actually, Steve, I'm going to turn that question to you. What, what I was gonna ask is sort of along those lines where we've seen various things that FDA has promoted and wanted, an example would be adaptive trials and so on, and I don't know, maybe you and Lauren together can talk about this, Lauren, you talked about ctDNA having being on the radar for such a long time, and I guess my question really is, does this sort of create a tipping point? Steven, your experience with FDA, are there things that are sort of long-term issues that you get a certain amount of momentum and then something happens and you get this change? Or does this just sit on the pile of a long to-do list? Because what I heard from Lauren is what now has to happen? People have to run these trials. They have to do prospective trials. That sounds to me like a very long road still before ctDNA can actually get embedded. So I don't either of you think of that..

Steve Usdin: 15:36

Well, I think the first got it was I, I spoke with Janet Woodcock about this and about similar things recently, and what she said is, you know, it doesn't make sense for anybody to sit around waiting for FDA to do anything in this context, or, or pretty much any context like this. They don't have the personnel now. They're not prioritizing this kind of activity at the moment. So if this is going to move forward, it's going to have to be by a kind of coalition of the willing, it's gonna have to be something like Friends of Cancer Research, but on a much bigger scale than I think what they've done to date. FNIH, some other kind of, of, um.

Simone Fishburn: 16:15

C-Path could do it actually Critical Path.

Steve Usdin: 16:17

Maybe C-Path if they, if they have, but this is a pretty big scale thing. I think this is bigger scale than anything that, that they've done also in the past. So all of those kinds of organizations, kind of public-private partnerships, I think could do it but it's going to require really substantial funding and it's gonna require collaboration from the, the regulators because nobody wants to get into something like this without having a good idea that at the end of it, it's going to have the potential to produce actionable data.

Lauren Martz: 16:46

I think there are different, there are different steps practically that need to happen for this too. So one of the challenges is that we don't know when, there's no standardization for when you're collecting this data, you know, CTD NA is going to exist at different levels, at different points in the treatment cycle after you've used a drug. So someone has to figure out when we should be measuring this. Should this be, should everyone take a CTD NA measurement four weeks after you start a trial or you know, whatever. There's also the issue of the type of assay that's used. So all of these things need to be sorted out by someone like Friends of Cancer Research, Critical Path, whoever can do it. Before it makes sense for companies to implement these in clinical trials in a standard way where you could collect the data and try to ultimately validate the endpoint. But so this issue of assay type I is another big challenge.

Simone Fishburn: 17:39

It's such an old issue though, Lauren. I really feel that there needs to be some kind of organizing principle or machinery for this, because you could go back to PD-1, right? Where the issue back then is everybody's developing it, use. Their own assay and that just makes it impossible for physicians to compare across products. And here you are also talking about assay standardization.

Lauren Martz: 18:03

Is higher.

Simone Fishburn: 18:03

I can think about this happening is during COVID, to be honest, when NIAID sort of forced the standardization of the COVID assays because otherwise everyone was talking about different things. So how do you look at that?

Lauren Martz: 18:16

I think this is even higher level than any of that. So there are two different types of assays, like classes of assays that you can use to measure ctDNA. One of them is this tumor informed assay where you take a tumor sample, sequence it, and then look for those specific sequences in the blood. So that can be very sensitive and that's really important if you're trying to detect if a cancer is coming back, you know, an early indicator of recurrence, which is what you want in that early disease setting. The problem is you need the tumor sample for that. Which doesn't always exist. And, and as we heard at the meeting, FDA has, has been to protect patients limiting the, um, amount of biopsies that are done, in some cases. So then the other type is a, a tumor agnostic, where you're just using more of a general search for different cancer signatures, not as sensitive, and that's a problem. So I think what ultimately may need to happen is the tumor agnostic assays need to become more sensitive. Something needs to happen to make these better so that they could be used in all settings, so you can standardize it. But that remains to be seen.

Simone Fishburn: 19:18

So what does your gut say? I mean, Lauren and Steve, what is, what does your gut say in terms of are we gonna be talking about this two years, three years, four years down the line without much progress? Or do you really think there's an opportunity for somebody to come in here? Is there even a business case for somebody to come in here and sort it out?

Steve Usdin: 19:36

Well, we're gonna be talking about this two years down the road for sure. It's not gonna get sorted out in the next two years, whether, um, there's gonna be a lot of progress in that timeframe or whether things are just going to kind of muddle along. You would hope that there will be a lot of progress. But somebody or some entity or some buddies, would have to, to step up and kind of take the bull by the horns and, and invest the, the money and the intellectual horsepower to make it happen. It won't happen on its own. And right now there's no obvious champion who has both the capability and the financial resources to make it happen. I think there, there are several organizations that we, as we mentioned, that maybe would have the capability to do it, but they would have also have to have the financial resources and then they would have to have the convening ability, which would include regulators and NIH and hopefully to do it on a global basis also to include scientific bodies and medical communities and regulators in the rest of the world.

Lauren Martz: 20:37

And I, I also wonder. If the scale that this is approached with will matter. So we, we saw MRD negativity get through and that was one indication, one treatment setting and a very clear goal. You don't wanna be able to find any residual disease. And, and that's not necessarily a blood-based test, but it's the same idea. But I mean, maybe we might see one very specific solid tumor setting, where ctDNA could be validated, by potentially a smaller group. This is a very big undertaking to say we're gonna completely transform endpoints in oncology for solid tumors. You know, there are differences in different tumor types and different therapeutics and, and how they impact ctDNA. I hope to see some progress, at least in some indications.

Simone Fishburn: 21:26

I'm just gonna go back and invoke COVID again, where you know, in that situation we just saw all of the pharmas get together and say, how do we solve this thing together. There's definitely a case for that, but there's really no framework for them still to be doing that. And they could be solving issues like that collectively. They've all got enough stake in this, in cancer, therapies,

Jeff Cranmer: 21:46

All right. Well thanks for that Lauren story, up on BioCentury.com. Give it a read. Let us know what you think. And while you're at it, uh, subscribe to BioCentury This Week podcast. All right, Steve, I've, I've gotta say I didn't, figure you for a Gunna fan, but, uh, your musical taste never ceases to impress me. Usually you're listening to some sort of obscure Japanese music or, or something that you've encountered in, in Georgia in your travels. But, uh, Gunna. I guess he, uh, likes taking the same stage as, uh, Stephen Ubl. Uh, maybe that's, that's it.

Steve Usdin: 22:28

Well, you know, I, I, I, I'm speechless. I don't know what to say about that. and, and I do have to confess that I have never listened to uh, Gunna and don't know what the music is about. But, you know, this is a good, a good way to introduce yeah, my story from last week. It's about a, the PhRMA Forum. I wanted to have a headline saying A funny thing happened to the forum, but I couldn't quite make it work. That was held at the Anthem, a big glitzy theater,

Jeff Cranmer: 22:53

Yeah, I, I, I splash cold water on that. I, I just didn't find much funny about what's happened in the past year, but the story did give, uh, me an opportunity to put in one of my favorite bands, the Flaming Lips. And, uh, I know that you're now interested upon learning that they often take the stage with 30 foot tall, inflatable jiggling pink robots. Uh, but we're here to talk about a different sort of thing that

Steve Usdin: 23:19

You know, actually and there, yeah, there was a, a kind of a 30 foot robot in the room during the, the meeting, at the PhRMA Forum last week. And, and the interesting thing is, is that he wasn't really discussed much. So last year, a year ago, um, they had, a similar event, in the same space. And, the CEOs of pharma companies and the CEO of PhRMA were falling all over themselves lavishing praise on President Trump. Albert Bourla, the CEO of Pfizer even said that, he was going to, make America great again, and that's what was gonna be great for the pharmaceutical industry and so on. This year, the CEOs didn't mention, Trump at all. What was interesting was, what they did talk about. So there were two things really. One was China. There was a great deal of discussion about China, and the other was, MFN. About China was interesting because, Steph Ubl, the, um, CEO of of PhRMA near the beginning, he came out and did his, um, opening, uh, keynote talk, and he started talking about statistics about China. He said China conducts Phase I trials 50% faster and 40% cheaper than the United States. The companies headquartered in China now conduct 30% of all clinical trials globally. Up from 5% a decade ago, and that they're on track to surpass the United States the next few years. And he also talked about the fact that, Chinese companies are not, simply developing me too drugs that they're innovating. There was a lot of discussion on the, on the stage about, what this means for the United States, what it means for the patients and, and, and so on. What wasn't discussed, which was interesting, is the amount of money that multinational corporations, including Pfizer, and Albert Bourla was, was in on these discussions, how much money they're investing in China, and how committed they are to expanding their China-based R&D and manufacturing footprints and integrating China into the global, pharma. ecosystem. There was one person there who, who did talk about that. Franck Le Deu, a former McKinsey leader. And, um, you know, and he basically said, look, when you're looking at it from the big picture that, It makes sense to think about China and say, you know, are they going to be bringing new, innovative drugs to patients, around the world? And if they are, then they should be welcome, to doing that. And he also said that it doesn't make so much sense to be as concerned as some of the people on the stage there seem to be about the Chinese biopharmaceutical industry because he said that the reality is that chinese companies are completely dependent on foreign markets that they don't have a large enough domestic market to sustain innovation. And that, there are very few Chinese companies that have the capability to, uh, be competitive on a global stage that they're gonna need to collaborate with companies from around the world, from the United States and from Europe and other parts of Asia to reach global markets.

Simone Fishburn: 26:16

Steve, I think that's really interesting. I, I think, you know Franck. always, he really brings, um, knowledge of somebody who's, I think he's lived in Hong Kong for over 20 years. I mean, he really understands that ecosystem in a much more sophisticated way. It's easy in many at BioCentury and many of the people we know would agree that we should welcome China into the ecosystem. So that's not necessarily specifically new, but understanding the threat that China companies do and don't actually pose, and the fact that they need to access the global markets is really interesting. How, how do you, um, you know, think about that. I wanna go back to your conversation with Peter Kolchinsky. where Peter Kolchinsky was really talking about how China can become, I mean, in the context of most favored nation, MFN, He was talking about how. MFN, you know, if it ends up just meaning certain countries won't get access to medicines, China has an opportunity there to say, we'll bring you a fifth in class and we'll do deals with you. And so there is this whole tension around. The development of the biotech ecosystem there where there's a lot of innovation, first order innovation, and there's also just a lot of capability and you know, the threat that they do and don't pose. And how do you reconcile these various different things that you are hearing?

Steve Usdin: 27:42

Well, what's difficult to reconcile and what I kind of, uh, alluded to at the beginning, is the view that the rise of, um, China's life sciences ecosystem, innovation ecosystem in particular, is something that, is detrimental to the United States or to the rest of the world. And at the same time, the enthusiasm, um, with which American and European and Japanese, companies are investing in China and welcoming them to this global ecosystem. So, you know, I, it, it, it's kind of hard to have it, both ways. I think that one of the other things that was really interesting, one of the things that came out of this conversation was the discussion about the steps that the United States needs to take regardless of what's done in China to improve the innovation ecosystem in the United States. Scott Gottlieb, the former FDA commissioner, noted that the Chinese government has undertaken deliberate steps to reformance regulatory process, to make, clinical trials, for example, much more seamless. as a result, it's far easier and quicker to launch first in human trials in China than elsewhere. Makes it possible for companies to iterate much more easily. And that's important for technologies like bispecific antibodies or CAR T. And then the interesting thing he said, and we could do something similar here in the United States. And I think that was one of the more interesting things that was said all day long. Basically the idea that the United States could learn, from some of the things that have helped China advance so rapidly and adopt some of the things in the United States.

Jeff Cranmer: 29:19

Steve, another story, uh, you wrote last week was on the U-turn by FDA leadership The initial, uh, refusal to file of a vaccine application from Moderna. What can companies learn from what transpired there?

Steve Usdin: 29:39

Yeah. So what transpired in short is that, FDA gave Moderna a lightning fast type a meeting after they refused to file and then came up with a, a path forward that will allow them to file, splitting the application into a Standard Application and a Accelerated Approval application for different age groups. So what I looked at that and I said, well, look, there's two questions. One is, um, what led to this reversal? And two, does it offer a replicable strategy for modifying or preempting adverse FDA decisions. The short answers are what led up to it is politics. And, can it be replicated? Probably not. It's probably a one-off, unique situation.

Jeff Cranmer: 30:23

Is, is there a precedent for splitting, uh, application like that?

Steve Usdin: 30:27

Not that I could find, and not, not that I knew, not where, where you're saying, you know, it's gonna get a standard review for, um, one age group and Accelerated Approval review for the other age group with exactly the same endpoints and exactly the same, um, indication. I'm not aware of that ever happening before. It, it clearly looks like it was a, you know, a face saving move. We still don't know, um, what's going to happen, um, going forward. Couple of data points that are interesting, the MAHA movement has reacted with fury, about the idea that FDA would review an mRNA based vaccine. This is a, a flu vaccine. And some of the leaders of the MAHA movement have said, uh, social media that, if the FDA approves an mRNA vaccine, that they shouldn't expect MAHA voters to come out for them in the midterms. Another thing that I found a little bit interesting is that Vinay Prasad, the Director of CBER, who was responsible for the, uh, refused to file letter in the first place, seems to be taking a low profile now. There were events, today around an announcement, uh, that FDA had for its Plausible Mechanism framework, Vinay Prasad is a kind of co-author of this framework and literally co-author of papers, um, that have been published discussing it, and he was nowhere to be seen. I don't really know what, what that means. But, it does seem that there's a lot of sensitivity in this administration around the vaccine issue. I know that there's polling that the White House has seen that shows that, uh, a majority of Americans favor of vaccines, they want their children to have access to vaccines. And as a result of that, I think it's likely that we're gonna see less you know, kind of straight up anti-vaccine activity and rhetoric from the administration in the in the runup to the election. But we don't know, getting back to the Moderna flu vaccine, what they're going to do. In this case, there are a number of scenarios where they could try to, um, slow walk it to avoid making a decision prior to the midterm elections. Problem with that is that they can't delay an action long past the beginning of August PDFUA date for this vaccine and still have it produced and, um, shipped and available to Americans in time for the flu season this year.

Jeff Cranmer: 32:50

All right. And, and we've discussed previously, and you've written about previously just the, uh, importance of mRNA vaccines. To get America ready for the next pandemic when it happens.

Steve Usdin: 33:02

Yeah. You know, and it's interesting. So I was at this Plausible Mechanism Pathway event. this morning. Somebody asked the FDA Commissioner Marty Makary about mRNA vaccines and Makary defended the administration's decision to deprioritize research, on mRNA vaccines to pull money away, even, you know, a great deal of money that it had already committed to mRNA vaccine development for pandemic preparedness and other things. And even though it's not an FDA issue, so I'm not quite sure why he was talking about it, but he did. And he said, well, look, those companies made so much money from other COVID vaccines that they don't need government support for developing mRNA vaccines. You know, it's an interesting argument

Jeff Cranmer: 33:46

Um, is it a common argument to come from an FDA Commissioner?

Steve Usdin: 33:50

No, it's, it's not, it's not something you, one, you don't really expect to hear an FDA Commissioner talking about BARDA or funding. And two, you know, I think that equating profits from vaccines that were developed for one kind of indication and saying that as a result of that, that the entire technology doesn't need investment from the federal government to develop it for other indications, is kind of a, a, a, a leap.

Jeff Cranmer: 34:18

Alright, well you can, uh, see Steve's story, about the Moderna issue up on BioCentury.com. we didn't get to it today, but we'll have a story, for you on the latest in obesity data from Stephen Hansen who follow the space quite closely, looking at what Novo Nordisk latest CagriSema data mean for the therapies, commercial prospects as well as for, Novo Nordisk bid to slow down Eli Lilly's takeover of the obesity market. thank you for tuning in, subscribe to our podcast and we will catch you next week. And a special thanks to Kendall Square Orchestra, which produces the music for our podcast, and what's next from them? Friday, March 13th, Mahler's sixth, that should be a good one, symphony number six, tragic. We will catch you next week.